NCT01100502 (Aethera Trial) (CLINICAL TRIAL / BRENTUXIMAB VEDOTIN / SGN-035 / ADCETRIS®)

Study Title
A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial) (NCT01100502)

Trial Description
This is a randomized, double-blind, placebo-controlled, multicenter phase III trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).

This trial is sponsored by Seattle Genetics/Millennium Pharmaceuticals. [1]

Study Data

  • Condition: Lymphoma
  • Interventions:
  • Phase: III
  • Enrollment: 329
  • Start: April 2010
  • Estimated Completion: April 2016
  • Last verified: March 2015
  • Last updated: April 12, 2016
  • Health Authority: United States Food and Drug Administration (FDA)

Study Schematic 

NCT01100502 (Aethera Trial) (CLINICAL TRIAL / BRENTUXIMAB VEDOTIN / SGN-035 / ADCETRIS®)
Fig 1.0: The AETHERA Trial is a Phase III Study of Brentuximab Vedotin, also known as SGN-35, in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant. PFS follow-up (year 2) included continued monitoring with scans at 18 and 24 months and quarterly clinical assessments. Patients in this trial who experienced disease progression per investigator during the study were unblinded and could receive brentuximab vedotin as part of a separate trial.

Trial Results
The AETHERA trial is a randomized, double-blind, phase III study of brentuximab vedotin and best supportive care (BSC) vs. placebo and BSC in Hodgkin lymphoma (HL) patients at increased risk of relapse or progression post-autologous stem cell transplant (ASCT). Early consolidation post-ASCT with brentuximab vedotin demonstrated improved progression-free survival (PFS) per independent review compared with placebo (median PFS 43 vs 24 months; HR = 0.57, p = 0.001). The most common treatment-emergent grade ≥3 adverse events (AEs) were neutropenia (29% brentuximab vedotin vs 10% placebo), peripheral sensory neuropathy (10% vs 1%), thrombocytopenia (4% vs 3%), peripheral motor neuropathy (6% vs 1%) and anaemia (4% vs 2%). Treatment discontinuation due to AEs occurred in 33% vs 6% of patients, and 53 patients died on study (17% vs 16%). [2]

Last Editorial review: June 10, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.